FDA device listing
50 Cannula,Anterior Chamber Cannula,Anterior Chamber Cannula [Rycroft],Bimanual I/A High Flow,Bimanual Irrigation…
FDA device listing 1396892894 · Beaver-Visitec International, Inc.
Key facts
| Proprietary names | 50 Cannula,Anterior Chamber Cannula,Anterior Chamber Cannula [Rycroft],Bimanual I/A High Flow,Bimanual Irrigation Cannula,Bishop Harmon Cannula,BVI Ophthalmic Cannula,Capsule Polisher,Coaxial I and A Cannula,Cortex Extractor,Cortical Cleaving Hydrodissector,FLACS Cannula,Flexible Tip Cannula,High Viscosity Injector,HydroExpression Cannula,I and A Cannula,Infusion Cannulas,Irrigating… |
|---|---|
| Owner/operator | Beaver-Visitec International, Inc. |
| Owner/operator number | 10033379 |
| Product codes | HMX |
| Device names | HMX - Cannula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | Beaver-Visitec International, Inc., Beaver-Visitec International, Ltd, Grupo American Industries, S.A. de C.V, Malosa Medical Instruments (Changshu) Limited |
| Establishment registrations | 1211998, 9680620, 3012733432, 3013421458, 3013466775 |
| FEI numbers | 1211998, 3002808441, 3012733432, 3013421458, 3013466775 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database